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This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]GP681 in healthy Chinese male volunteers, revealing the overall pharmacokinetic characteristics of GP681 in humans, and providing a reference for the rational administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]GP681 | Experimental | Subject will receive single dose of orally [14C] GP681 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] GP681 | Drug | 40 mg suspension containing 100μCi of [14C]GP681 |
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| Measure | Description | Time Frame |
|---|---|---|
| The distribution of GP681 in the whole blood and plasma, and the radioactive pharmacokinetics following the single orally administered [14C]GP681 in healthy Chinese male volunteers. | The percentage of radioactive dose of [14C] radiolabelled GP681 recovered in blood and in total. | Up to 336 hours (approx) from the start of administration. |
| Quantitive analysis of whole radioactivity of excrement of orally administered [14C]GP681 in healthy Chinese male subjects to obtain the mass balance data and the main excretion pathway in human body. | The percentage of radioactive dose of [14C] radiolabelled GP681 recovered in urine, faeces and in total. | Up to 432 hours (approx) from the start of administration. |
| Quantitive analysis of the concentrations of GP681 and its major metabolites (such as GP1707D07) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data. | The concentrations of GP681 and its major metabolites in plasma. | Up to 336 hours (approx) from the start of administration. |
| Identification of the main metabolites and biotransformation pathway of GP681 following the single orally administered [14C]GP681 in healthy Chinese male volunteers | Proportion of different metabolites. | Up to 432 hours (approx) from the start of administration. |
| Evaluation of safety following the single orally administered [14C]GP681 in healthy Chinese male volunteers. | Adverse events assessed by NCI-CTCAE v5.0. | Up to 432 hours (approx) from the start of administration. |
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Inclusion Criteria:
Exclusion Criteria:
age of 18-40 (inclusive)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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Open-label, radiolabeled, single-dose study of an oral solution of [14C]GP681(40mg/100μCi) in 6 healthy male volunteer.
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Nonrandomized and open labeled study
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